According to the latest American Heart Association statistics, one out of every six deaths in the U.S. is attributed to coronary heart disease. Each year, an estimated 785,000 Americans will have an initial heart attack, and 470,000 will have a recurrent attack – that’s approximately one every 34 seconds. Even more alarming, it’s estimated that an additional 195,000 “silent” heart attacks occur each year without warning.

Cardiologists at the Catholic Health Heart Center at Mercy Hospital of Buffalo are studying a new investigational medical device, the AngelMed Guardian System, which can alert patients of an imminent heart attack – often before they have any symptoms. The device is implanted like a pacemaker and monitors the patient’s heart continuously, sending a series of alarms if it detects changes that may signal an impending heart attack.

Minutes Saved Means Lives Saved

“Every minute saved in getting patients to the hospital before a heart attack occurs can translate to lives saved and possibly improved outcomes for heart attack victims,” said Irfan Khan, MD, a cardiologist and director of the Electrophysiology Labs at Mercy Hospital, who performed one of the first AngelMed implants in New York State, and is among the first physicians in the U.S. to implant the device.

Participating Physicians

Dr. Khan, a primary investigator in AngelMed’s ALERTS Clinical Study, with interventional cardiologist Joseph Gelormini, MD, both of the Buffalo Heart Group, joined the study in 2011. In addition, interventional cardiologist and primary investigator Salvatore Calandra, MD, director of Interventional Cardiology at Mercy Hospital, and electrophysiologist Rob Wall, DO, of the Cardiology Group of WNY, joined the study in June.

How the AngelMed Guardian System Works

The AngelMed Guardian System includes an internal implantable monitor and a wireless external device. The system is designed to measure significant changes in the heart’s electrical signal. When the internal device detects a potential heart attack, it vibrates alerting patients to seek medical attention. The external device also beeps and flashes letting patients know that they should call their doctor or 911. Once AngelMed patients arrive at the hospital, doctors can retrieve information collected by the implantable device to determine the best course of treatment.

Study Measures Safety and Effectiveness

The objective of the ALERTS Study is to determine the safety and effectiveness of the AngelMed Guardian System. “This research study provides an excellent opportunity for patients who are at high-risk of having another heart attack,” said Dr. Khan. “By giving them this advanced warning, they can seek medical attention at the earliest onset of a heart attack so treatment can begin as soon as possible to prevent further heart damage.”

Peace of Mind for Cardiac Patient James Hess

James Hess, a 58 year-old Buffalo resident with an extensive cardiac history, is one of the first patients in New York enrolled in the ALERTS study and received the AngelMed Guardian System in June of 2012. Hess first underwent cardiac bypass surgery in 1997. Two more visits to the ER followed, before he elected to participate in the ALERTS Study.

Being part of the study has given Hess greater peace of mind. “Heart patients have to make so many lifestyle changes, it’s comforting to know that I can have an active lifestyle and not be afraid to enjoy myself,” he said. “I hope that this trial will benefit generations to come.”

More Information

The Catholic Health Heart Center at Mercy Hospital of Buffalo is among the first medical facilities in the country to participate in the AngelMed Guardian system trial.

To participate in the ALERTS study, patients must meet various inclusion criteria.

For more information on the AngelMed Guardian system or the ALERTS study protocol, contact Jodi Skinner at 716-835-2966 or email at jskinner@buffaloheartgroup.com; or contact Kyle Mann at Cardiology Group of Western New York at 716-634-3243 or email at kmann@cgwny.com .